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Global Development
Session Chair(s)
Jennifer Paine, MS, RAC
Executive Vice President, Worldwide Quality, Regulatory and Compliance
Ortho Clinical Diagnostic, United States
As the market for global drug device combination products is expected to reach $30 billion by 2014, understanding international access challenges and regulatory changes is essential. In particular, changes to the Medical Device Directive in the EU will impact combination product oversight, and globally there are differences in how combination products are viewed by regulators. This session will provide overviews and insight into regulatory requirements and expectations of global markets.
Speaker(s)
Bridging
Erik Vollebregt, JD, LLM
AXON Lawyers, Netherlands
Partner
Multi-market Access Challenges
Elizabeth Baker
Medicines and Healthcare Products Regulatory Agency (MRHA), United Kingdom
Group Manager Licensing Division
EU Regulatory Changes
Paul C. Brooks
Regulatory Affairs Professionals Society (RAPS), United States
Executive Director
Panel Discussion
All Session Speakers, United States
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